Bioprocess Specialist

Hyde Engineering + Consulting; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading engineering consultancy in Canada is seeking a Process Engineer to support the design phase of a new biopharmaceutical production facility. This role involves technical decision-making and project documentation within a collaborative team, focusing on cGMP-compliant operations. If you have a degree in engineering and relevant industry experience, consider joining a team dedicated to enhancing pharmaceutical manufacturing for better healthcare outcomes.

Benefits

Equal opportunity employer

Contribution to health-oriented projects

Qualifications

• 5-8 years experience in the Biopharmaceutical industry.
• Demonstrated engineering project management experience in construction.
• Excellent knowledge of ASME BPE, ISPE, FDA cGMP requirements.

Responsibilities

• Support/lead the design and specification of cGMP equipment.
• Create and review project documentation such as URS, FRS.
• Specify requirements for tanks, valves, pumps, centifuges.

Skills

Project Management

Process Design

Communication

cGMP Knowledge

Education

BS degree in chemical or mechanical engineering

Tools

Microsoft Office

Job description

The Process Engineer would support the design phase (conceptual, basis of design, detailed design) of a new production facility. This includes supporting FAT’s off-site, construction, SAT’s, commissioning, and field engineering for the final phases of the project.

Responsibilities

• Support / lead the design and specification of cGMP equipment, processes and utilities for biopharma projects.
• Create and review project documentation (URS, FRS, Technical Specifications, Functional Specifications)
• Create and review process models and sizing calculations for process equipment, control valves etc
• Manage and populate equipment / line / valve / instrument lists and equipment data sheets
• Liaise with client end user groups to ensure correct specification of equipment and utilities
• Create Technical Specification and Functional Specification for automated and manual equipment
• Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF / DF systems, chromatography columns
• Sizing and specification of utility systems (clean and plant); RODI, PW, WFI, Clean Steam, Plant Steam, Clean Compressed Air, Other Process Gases, & Waste Systems.
• Provide engineering expertise and drive technical decisions as active member

Desired Skills and Experience

• BS degree or higher in chemical or mechanical engineering
• 5-8 experience in the Biopharmaceutical industry, preferably in a consulting capacity
• Must have demonstrated engineering project management experience ideally in a construction environment
• Familiarity with process design and operations (block flow diagrams, process flow diagrams, etc…)
• Experience with downstream processing experience (TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, purification)
• Experience with Fill / Finish
• Experience with startup, walkdowns, as-built P&IDs, FAT, SAT and commissioning
• Experience with clean utilities and drop points, connections, drain and waste systems
• Excellent knowledge of ASME BPE, ISPE and FDA cGMP requirements
• Strong verbal and written communication skills
• Ability to work independently and within project teams.
• Industry experience related to cGMP drug manufacturing, validation, and chemical process design
• Strong computer knowledge including Microsoft Office products

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website : www.hyde-ec.com

Hyde is an equal opportunity, affirmative action employer.